Active — Not RecruitingPhase 3

Olorofim Aspergillus Infection Study

United States225 participantsStarted 2022-03-31

Plain-language summary

The purpose of this study is to compare treatment with olorofim versus treatment with AmBisome® followed by standard of care (SOC) in patients with IFD caused by proven IA or probable lower respiratory tract disease Aspergillus species (invasive aspergillosis, IA).

Who can participate

Age range18 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

✓. Male and female patients ages over 18 years and weighing more than 30 kg
✓. Patients with proven IA at any site or probable LRTD IA per EORTC/MSG 2019 criteria as adapted for this study and where the duration of specific therapy for this episode of IA has been ≤ 28 days. For purposes of this inclusion, the duration of specific therapy includes any mould-active therapy given for this episode of IA whether subsequently judged potentially effective or not.

Exclusion criteria

✕. AmBisome® is an appropriate therapy for the patient.
✕. Women who are pregnant or breastfeeding.
✕. Known history of allergy, hypersensitivity, or any serious reaction to any component of the study drug
✕. Patients with only chronic aspergillosis, aspergilloma, or allergic bronchopulmonary aspergillosis.
✕. Suspected mucormycosis (zygomycosis).
✕. Patients with a known active second fungal infection of any type, other than candidiasis that can be treated with fluconazole.
✕. The requirement for ongoing use of echinocandin as Candida prophylaxis.
✕. Microbiological findings (eg, bacteriological, virological) or other potential conditions that are temporally related and suggest a different aetiology for the clinical features.

What they're measuring

All-cause mortality

Timeframe: Treatment Day 42

Trial details

NCT IDNCT05101187

SponsorF2G Biotech GmbH

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2025-11-18

View on ClinicalTrials.gov More Invasive Aspergillosis trials